Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of CRD-102 in a Fasted and Fed state in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: heart failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12615001228572
• Lead Sponsor: Cardiora Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

1.Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
2.Be male aged 18 to 45 years old at the time of consent and willing to use an acceptable method of contraception for the duration of the study
3.Be in good general health without clinically significant medical history
4.Have a body mass index (BMI) between 19- 30 kg/m2 inclusive
5.Have a documented 12-lead ECG with no clinically significant abnormalities, as determined by the Investigator.
6.Have no clinically significant abnormalities in screening or Day -1 laboratory tests, as determined by the Investigator
7.Have negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test results
8.Have no dietary restrictions, and be willing to consume standard meals provided

Exclusion Criteria

1.Receipt of any investigational agent or drug within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational product
2.Use of prescription drugs within 4 weeks prior to first dosing.
3.Use of over the counter medications in the 2 weeks (4 weeks for St. John’s Wort) prior to dosing, with the exception of paracetamol or topical over the counter medications with no evidence of systemic absorption.
4.Clinically relevant findings in the medical history, laboratory examination and physical examination, especially with regards to cardiovascular system and renal function
5.A positive urine test for drugs of abuse or alcohol at Screening or on the day of admittance to the Study Unit
6.Any major surgical procedure within one month of entry into the study
7.Have difficulties communicating reliably with the Investigator or unlikely to co-operate with the requirements of the study.
8.Any other condition which in the view of the Investigator is likely to interfere with study or put the subject at risk.

Study & Design

• Study Type: Interventional
• Study Design: Not specified